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ClinicalTrials.gov 28 recruiting now early-phase tilt

HER2-positive Breast Cancer: early-phase trial registry

28 of 59 indexed HER2-positive Breast Cancer trials are currently recruiting, with more weight in Phase 1-2.

Corpus placement: #241 of 28,707 conditions by registered trial count.

59 US clinical trials · 28 currently recruiting · #241 of 28,707 conditions by registered trial count

HER2-positive Breast Cancer: 59 US clinical trials tracked, 28 recruiting.

HER2-positive Breast Cancer is the subject of 59 registered US clinical trials on ClinicalTrials.gov, 28 of them currently open to new participants. 4 are in Phase 3-4 (later-stage) and 46 in Phase 1-2 (earlier-stage). The most active sponsor is H. Lee Moffitt Cancer Center and Research Institute, running 7 of these trials.

Enrollment posture brief

Registry condition her2-positive-breast-cancer

OPEN 28 | RECR 47% | LATE 4 | EARLY 46 | RANK #241 | SPON 7

Nearest open-share peer: Metastatic Lung Non-Small Cell Carcinoma (48% recruiting · 40 trials)

Anatomic Stage IV Breast Can70%Hearing Loss50%HER2-positive Breast Can (th…47%Substance Abuse15.3%Opioid-Related Disorders13.6%
Open-enrollment share among volume-matched conditions near HER2-positive Breast Cancer

HER2-positive Breast Cancer lists 28 open slots (47% of 59 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for HER2-positive Breast Cancer on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. HER2-positive Breast Cancer is recruiting above its size-band peers.

    28 of 59 indexed trials (47.5%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. Sponsorship of HER2-positive Breast Cancer trials is spread across many organizations.

    H. Lee Moffitt Cancer Center and Research Institute accounts for 7 of 59 trials (11.9%). 38 distinct sponsors appear on at least one study for this condition label.

  3. Typical HER2-positive Breast Cancer enrolment sits around 63 participants.

    Median target enrolment is 63 among the 59 trials that report a genuine target (sentinel values excluded). 33 of those (55.9%) plan for fewer than 100 participants.

  4. HER2-positive Breast Cancer research is mostly interventional.

    55 interventional and 4 observational studies make up this index (93.2% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 118Phase 228Phase 34

Open and recent trials

59 total, page 1 of 2

RECRUITING Phase 2 5,000 participants

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

QuantumLeap Healthcare Collaborative

NCT01042379

RECRUITING Phase 3 1,300 participants

Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer

NRG Oncology

NCT05705401

RECRUITING Phase 2 500 participants

ATEMPT 2.0: Adjuvant T-DM1 vs TH

Dana-Farber Cancer Institute

NCT04893109

RECRUITING Phase 2 375 participants

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Dana-Farber Cancer Institute

NCT04569747

RECRUITING NA 260 participants

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

University of Miami

NCT06123988

RECRUITING Phase 1 243 participants

A Phase 1/1b Study of IAM1363 in HER2 Cancers

Iambic Therapeutics

NCT06253871

RECRUITING NA 214 participants

Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Brigham and Women's Hospital

NCT04030507

RECRUITING Phase 2 185 participants

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Baylor Breast Care Center

NCT05020860

RECRUITING 170 participants

Study of Screening Brain MRIs in Stage IV Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05115474

RECRUITING Phase 2 165 participants

PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

MedSIR

NCT06172127

RECRUITING Phase 2 162 participants

A Study of Surgery and Radiotherapy in People With Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT07053085

RECRUITING Phase 1 162 participants

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2

Mersana Therapeutics

NCT05514717

RECRUITING Phase 2 125 participants

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Jazz Pharmaceuticals

NCT07102381

RECRUITING Phase 1 124 participants

PRE-I-SPY Phase I/Ib Oncology Platform Program

QuantumLeap Healthcare Collaborative

NCT05868226

RECRUITING Phase 2 72 participants

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Dana-Farber Cancer Institute

NCT06439693

RECRUITING Phase 2 63 participants

TRUDI: TDXD+Durva in HER2+/Low IBC

Filipa Lynce, MD

NCT05795101

RECRUITING Phase 2 60 participants

HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission

Memorial Sloan Kettering Cancer Center

NCT07459673

RECRUITING Phase 2 53 participants

Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

H. Lee Moffitt Cancer Center and Research Institute

NCT05325632

RECRUITING Phase 1 42 participants

HER-2 B Cell Peptide Vaccine

Pravin T.P Kaumaya

NCT06414733

RECRUITING Phase 1 39 participants

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

H. Lee Moffitt Cancer Center and Research Institute

NCT04588545

RECRUITING Phase 1 36 participants

HER2 Vaccine for Locally Advanced Breast Cancer

Pravin T.P Kaumaya

NCT06949410

RECRUITING Phase 2 30 participants

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

Ruth O'Regan

NCT04886531

RECRUITING Early Phase 1 30 participants

Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Alison Stopeck

NCT06220214

RECRUITING Phase 1 28 participants

Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05378464

RECRUITING Phase 2 28 participants

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer

University of Illinois at Chicago

NCT06441890

RECRUITING Phase 1 25 participants

Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI

University of Alabama at Birmingham

NCT04332588

RECRUITING Phase 1 18 participants

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)

H. Lee Moffitt Cancer Center and Research Institute

NCT05809752

RECRUITING NA 15 participants

NearWave Optical Molecular Monitoring

Indiana University

NCT06744465

ACTIVE NOT RECRUITING Phase 3 654 participants

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Seagen, a wholly owned subsidiary of Pfizer

NCT05132582

ACTIVE NOT RECRUITING Phase 3 518 participants

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Alliance Foundation Trials

NCT02947685

ACTIVE NOT RECRUITING Phase 3 466 participants

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Seagen, a wholly owned subsidiary of Pfizer

NCT03975647

ACTIVE NOT RECRUITING Phase 1 275 participants

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

Enliven Therapeutics

NCT06328738

ACTIVE NOT RECRUITING Phase 1 210 participants

A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors

Hoffmann-La Roche

NCT05593094

ACTIVE NOT RECRUITING Phase 2 174 participants

MARGetuximab Or Trastuzumab (MARGOT)

Dana-Farber Cancer Institute

NCT04425018

ACTIVE NOT RECRUITING Phase 2 164 participants

T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

Dana-Farber Cancer Institute

NCT02326974

ACTIVE NOT RECRUITING Phase 2 138 participants

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]

University of Texas Southwestern Medical Center

NCT03747120

ACTIVE NOT RECRUITING Phase 2 134 participants

Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases

Brigham and Women's Hospital

NCT04899908

ACTIVE NOT RECRUITING Phase 2 134 participants

A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging

Northwestern University

NCT02993198

ACTIVE NOT RECRUITING Phase 2 119 participants

Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT03384914

ACTIVE NOT RECRUITING Phase 2 82 participants

STOP-HER2: Stopping Trastuzumab in HER2+ MBC

Dana-Farber Cancer Institute

NCT05721248

ACTIVE NOT RECRUITING Phase 2 63 participants

Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer

City of Hope Medical Center

NCT01730833

ACTIVE NOT RECRUITING Early Phase 1 31 participants

HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT03387553

ACTIVE NOT RECRUITING Phase 2 28 participants

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)

Adrienne G. Waks

NCT06100874

ACTIVE NOT RECRUITING Phase 1 24 participants

HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases

City of Hope Medical Center

NCT03696030

ACTIVE NOT RECRUITING 23 participants

Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity

Memorial Sloan Kettering Cancer Center

NCT05036252

ACTIVE NOT RECRUITING Phase 2 17 participants

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer

Mayo Clinic

NCT03179904

ACTIVE NOT RECRUITING Phase 2 16 participants

Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

Fox Chase Cancer Center

NCT03125928

ACTIVE NOT RECRUITING 13 participants

Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

University of Washington

NCT03738553

ACTIVE NOT RECRUITING NA 12 participants

Omission of Radiation in Patients With Her-2 Positive Breast Cancer

University of Kansas Medical Center

NCT03460067

ACTIVE NOT RECRUITING NA 10 participants

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

City of Hope Medical Center

NCT02226276

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Phase Distribution

PhaseTrial count
Phase 1 18
Phase 2 28
Phase 3 4

Named interventions

Most-linked intervention names on HER2-positive Breast Cancer records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

Trastuzumab Drug
15 trials
Pertuzumab Drug
10 trials
Paclitaxel Drug
9 trials
trastuzumab Biological
4 trials
T-DM1 Drug
3 trials
Docetaxel Drug
3 trials
trastuzumab Drug
2 trials
tucatinib Drug
2 trials

US sites by state

Facility locations filed on HER2-positive Breast Cancer trials. A trial with sites in several states counts in each.

Florida 23 trials
Massachusetts 17 trials
California 17 trials
New York 14 trials
Texas 10 trials
Illinois 10 trials
Arizona 10 trials
Washington 8 trials

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

What to do with this HER2-positive Breast Cancer page

59 registered trials, 28 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This HER2-positive Breast Cancer condition card totals 59 registered trials; most-linked intervention Trastuzumab; top US site state Florida. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.